NIPH Clinical Trials Search

UMIN ID: C000000022

Registered date:07/07/2005

Capecitabine/cyclophosphamide combination therapy for patients with advanced or metastatic breast cancer who have been previously treated with anthracyclines - a phase 2 study

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedBreast cancer
Date of first enrollment2005/07/01
Target sample size70
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)chemotherapy capecitabine 1657mg/m2, cyclophosphamide 65mg/m2, q3w, 6cycles


Primary OutcomeResponse rate
Secondary OutcomeProgression-free survival(PFS), overall survival(OS), adverse event

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximum74years-old
Include criteria
Exclude criteria1)Pregnant or breast feeding 2)Documented history of serious hypersensitivity reaction on the medical drugs 3)Patients who have experienced prior chemotherapy with capecitabine 4)With metastasis to the central nervous system 5)Serious underlying medical illness with heart, gastrointestinal tract, or infection

Related Information


public contact
Address 45-1, 7-chome, Nanakuma, Jonan-ku, Fukuoka Japan Japan
Telephone 092-801-1011
Affiliation Kyushu Breast Cancer Study Group Executive Office
scientific contact
Name Shousyu Mitsuyama
Address 1-1, 2-chome, Bashaku, Kokurakita-ku, Kitakyusyu Japan Japan
Telephone 093-541-1831
Affiliation Kitakyusyu Municipal Medical Center Surgery